Sorafenib Tosylate in Treating Patients With Liver Cancer Who Have Undergone a Liver Transplant
|Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Resectable Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer||Drug: sorafenib tosylate Other: laboratory biomarker analysis||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Adjuvant Trial of Sorafenib in Hepatocellular Carcinoma Patients After Liver Transplantation|
- Dose-limiting toxicity (DLT) as defined by the Common Terminology for Adverse Events (CTAE) version 3 [ Time Frame: 28 days ]Defined as grade >= 3 nonhematologic/hematologic toxicity
|Study Start Date:||January 2009|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (adjuvant sorafenib tosylate after liver transplant)
Patients receive sorafenib tosylate PO twice daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate
Other Names:Other: laboratory biomarker analysis
I. Establish the safety and toxicity profile of sorafenib administered daily to hepatocellular carcinoma (HCC) patients who have undergone orthotopic liver transplantation.
I. Determine explant and allograft expression of vascular endothelial growth factor (VEGF), platelet derived growth factor receptor (PDGFR), microvessel density (CD34) and Ki67 (proliferation marker).
OUTLINE: Patients receive sorafenib tosylate orally (PO) twice daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844168
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Edward Lin||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|